FDA Approves Treatment for Smallpox Vaccination Side Effects

Mar 03, 2005

By PharmTech Editors

Pharmaceutical Technology

FDA Approves Treatment for Smallpox Vaccination Side Effects

DynPort Vaccine Company LLC (Frederick, MD, www.dynport.com) has received approval from the US Food and Drug Administration for a drug to treat adverse reactions to vaccinia virus, the live vaccine used in smallpox vaccines.

Because the smallpox vaccination contains a live virus, inoculated patients may develop serious, potentially life-threatening side effects including a severe, toxic rash that can spread to other individuals. In the past, serious reactions had occurred in 1000 out of every 1 million people vaccinated, according the Centers for Disease Control and Prevention.

DynPort’s intravenous vaccinia immune globulin (VIGIV) treatment contains purified antibodies specific to the vaccinia virus and is designed to help patients recover from severe rashes caused by the smallpox vaccine. Currently, the treatment is available only to the US military.

The company developed the VIGIV treatment platform as part of the Department of Defense’s Joint Vaccine Acquisition Program (JVAP) and is the first FDA-licensed product for DynPort and JVAP. VIGIV received fast-track and orphan drug status from FDA. Other products under development using the VIGIV technology include vaccines for botulinum, plague, tularemia, and Venezuelan equine encephalitis.